Adipose Tissue-derived Mesenchymal Stem Cell (AD-MSC) Therapy for the Treatment of Sexual Function Impairment in Female

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age40-65
SponsorVinmec Research Institute of Stem Cell and Gene Technology

About this trial

Hormones are a chemical substance synthesized and secreted by endocrine gland. Several vital hormones, including Mullerian hormone (AMH), follicle-stimulating hormone (FSH), and Estradiol (E2), play crucial roles in regulating female sexual function.- Hormone therapy is used to treat female hormone deficiency and results in a significant improvement, but long-term use increases cardiovascular disease or cancer risk. Other treatments do not give apparent results. Therefore, it is necessary to develop new and effective treatments to achieve the requirements of improving health in general and sexual health in particularly in women. AD-MSCs have been widely used as autologous and allogeneic stem cell sources to treat numerous disease recently, and they have been proven to be safe. The phase I trial showed that administration of autologous AD-MSCs at the dose of 1.0 x 10\^6 cells/kg patient bodyweight was safe for patients with sex hormone deficiency. The therapy introduced potential improvement in sexual and general quality of life indicating by the increased FSFI. Therefore, this phase II trial to evaluate efficiency of autologous adipose tissue-derived mesenchymal stem cells therapy in treatment of female patients with sexual function impairment.

Eligibility criteria

Qualifiers

Women who are 40 - 50 years of age or older and have not gone through menopause according to Stages of Reproductive Aging Workshop (STRAW) 2011

The last menstrual period before participating in the study at least 2 months or more

+ FSH > 40 mIU/mL

+ Estradiol < 30 pg/mL

Disqualifiers

Previous surgery to remove gonads

No sexual activity

Diagnosed with cancer and is being or has not been treated

Had an organ transplant

Trial design

Treatments tested in this trial

  • Autologous adipose-derived mesenchymal stem cell administration for female with sexual functional deficiency

Treatment groups

130 Participants
are divided into 2 treatment groups